U.S. patent application number 11/358311 was filed with the patent office on 2006-10-12 for tissue fixation system and method.
Invention is credited to Peter M. Bonutti, Larry Crainich, Glen A. Phillips.
Application Number | 20060229623 11/358311 |
Document ID | / |
Family ID | 46323904 |
Filed Date | 2006-10-12 |
United States Patent
Application |
20060229623 |
Kind Code |
A1 |
Bonutti; Peter M. ; et
al. |
October 12, 2006 |
Tissue fixation system and method
Abstract
A tissue fixation system is provided for dynamic and rigid
fixation of tissue. A fastener connected with an elongate fastening
member, such as a cable, wire, suture, rod, or tube, is moved
through a passage between opposite sides of tissue. The fastener is
provided with a groove that accommodates at least a portion of the
fastening member to reduce the profile during the movement through
the passage. The fastener is then pivoted to change its
orientation. A second fastener can then be connected with the
fastening member. While tension is maintained in the fastening
member, the fasteners are secured against relative movement. This
may be done by deforming the fastening member, either the first or
second fasteners, or a bushing placed against the second
fastener.
Inventors: |
Bonutti; Peter M.;
(Effingham, IL) ; Phillips; Glen A.; (Effingham,
IL) ; Crainich; Larry; (Charlestown, NH) |
Correspondence
Address: |
PAUL D. BIANCO: FLEIT, KAIN, GIBBONS,;GUTMAN, BONGINI, & BIANCO P.L.
21355 EAST DIXIE HIGHWAY
SUITE 115
MIAMI
FL
33180
US
|
Family ID: |
46323904 |
Appl. No.: |
11/358311 |
Filed: |
February 21, 2006 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
60655140 |
Feb 22, 2005 |
|
|
|
Current U.S.
Class: |
606/74 |
Current CPC
Class: |
A61F 2002/30677
20130101; A61B 17/0487 20130101; A61B 17/8863 20130101; A61B 17/82
20130101; A61B 17/0401 20130101; A61B 2090/035 20160201; A61F 2/442
20130101; A61F 2210/0004 20130101; A61B 17/685 20130101; A61B
2017/0409 20130101; A61F 2/28 20130101; A61B 17/0467 20130101; A61B
2017/0414 20130101; A61F 2002/4435 20130101; A61B 2017/06176
20130101; A61B 2017/0417 20130101; A61B 2017/2926 20130101; A61F
2/08 20130101; A61F 2310/00293 20130101; A61B 2017/0496 20130101;
A61B 17/8861 20130101; A61F 2002/2817 20130101; A61B 17/683
20130101; A61B 17/7053 20130101; A61F 2002/30062 20130101; A61B
2017/0488 20130101; A61B 17/8869 20130101; A61B 2090/064 20160201;
A61B 17/0469 20130101; A61B 17/1615 20130101; A61B 90/40 20160201;
A61B 2017/0458 20130101; A61B 17/0218 20130101; A61B 17/842
20130101; A61F 2002/444 20130101; A61B 17/844 20130101 |
Class at
Publication: |
606/074 |
International
Class: |
A61B 17/56 20060101
A61B017/56 |
Claims
1. A tissue fixation system comprising: an elongate fastening
member; and a fastener positionable on the elongated fastening
member and movable from a first orientation to a second
orientation, the fastener having a body with a tissue contacting
surface that includes a groove configured and dimensioned to
receive a portion of the elongate fastening member in the first
orientation.
2. The tissue fixation system of claim 1 wherein the fastener body
has a free surface opposite the tissue contacting surface, the free
surface including a channel configured and dimensioned to receive a
portion of the elongate member in the first orientation.
3. The tissue fixation system of claim 2 wherein the fastener body
includes a through bore extending from the tissue contacting
surface through the free surface.
4. The tissue fixation system of claim 3 wherein the fastener body
includes leading and trailing ends, the groove terminating at the
through bore and extending toward one of the leading and trailing
ends and the channel terminating at the through bore and extending
toward the other of the leading and trailing ends.
5. The tissue fixation system of claim 4 wherein the groove extends
toward the leading end and the channel extends toward the trailing
end.
6. The tissue fixation system of claim 5 wherein the free surface
of the fastener body includes a well surrounding the through
bore.
7. The tissue fixation system of claim 6 wherein a distal end of
the elongate fastening member includes a stop larger than the
through bore.
8. The tissue fixation system of claim 7 wherein the well is
configured and dimensioned to receive at least a portion of the
stop.
9. The tissue fixation system of claim 8 wherein the leading end of
the fastener body is tapered.
10. The tissue fixation system of claim 1 further comprising a
biasing means maintaining the fastener in the first
orientation.
11. The tissue fixation system of claim 10 wherein the biasing
means comprises an adhesive between the groove and the portion of
the elongate fastening member received in the groove.
12. The tissue fixation system of claim 10 wherein the biasing
means comprises a frangible connection between the groove and the
portion of the elongate fastening member received in the
groove.
13. A tissue fixation system for fixation of a first tissue member
to a second tissue member, comprising: an elongate fastener member
positionable though the first and second tissues members and
including first and second ends, such that the first and second
tissue members are interposed between the first and second ends of
the elongate fastener member; a first fastener positionable on the
first end on the elongate fastener member, adjacent to the first
tissue member; and a second fastener positionable on the second end
on the elongate fastener member, adjacent to the second tissue
member; wherein a tension is provided through the elongate fastener
member between the first and second fasteners, affixing the first
tissue member to the second tissue member.
14. A tissue fixation system as set forth in claim 13 wherein the
first fastener is moveable with respect to the elongate fastener
member from a first orientation to a second orientation, the first
fastener having a body with a tissue contacting surface that
includes a groove configured and dimensioned to receive a portion
of the elongate fastener member in the first orientation.
15. The tissue fixation system as set forth in claim 14 wherein the
first fastener body has a free surface opposite the tissue
contacting surface, the free surface including a channel configured
and dimensioned to receive a portion of the elongate fastener
member in the first orientation.
16. The tissue fixation system as set forth in claim 15 wherein the
first fastener body includes a through bore extending from the
tissue contacting surface through the free surface, through which
the elongate fastener member extends.
17. The tissue fixation system as set forth in claim 14 wherein the
first fastener body includes leading and trailing ends, the groove
terminating at the through bore and extending toward one of the
leading and trailing ends and the channel terminating at the
through bore and extending toward the other of the leading and
trailing ends.
18. The tissue fixation system as set forth in claim 17 wherein the
groove extends toward the leading end and the channel extends
toward the trailing end.
19. The tissue fixation system as set forth in claim 18 wherein the
free surface of the first fastener body includes a well surrounding
the through bore.
20. The tissue fixation system as set forth in claim 19 wherein the
first end of the elongate fastener member includes a stop larger
than the through bore.
21. The tissue fixation system as set forth in claim 20 wherein the
well is configured and dimensioned to receive at least a portion of
the stop.
22. The tissue fixation system as set forth in claim 21 wherein the
leading end of the first fastener body is tapered.
23. The tissue fixation system as set forth in claim 14 further
comprising a biasing means maintaining the first fastener in the
first orientation.
24. The tissue fixation system as set forth in claim 23 wherein the
biasing means comprises an adhesive between the groove and the
portion of the elongate fastener member received in the groove.
25. The tissue fixation system as set forth in claim 23 wherein the
biasing means comprises a frangible connection between the groove
and the portion of the elongate fastener member received in the
groove.
26. A tissue fixation system as set forth in claim 14 further
comprising a bushing member positionable on the second end of the
elongate fastener member, adjacent to the second fastener, wherein
the bushing member is affixable about to the second end of the
elongate fastener member.
27. A tissue fixation system as set forth in claim 26 wherein the
second fastener comprises a second fastener body including: a
tissue contacting surface; a free surface opposite the tissue
contacting surface; a through bore extending from the tissue
contacting surface through the free surface, through which the
elongate fastener member extends; and a well surrounding the
through bore, wherein the bushing is positionable in the well
surrounding the bore.
28. A tissue fixation system as set forth in claim 14 wherein the
second fastener comprises: a tissue contacting surface; a free
surface opposite the tissue contacting surface; and a through bore
extending from the tissue contacting surface through the free
surface, wherein the second end of the elongate fastener members
extends through the bore and the bore is affixable about the second
end of the elongate fastener member.
29. A tissue fixation system as set forth in claim 13 wherein the
first fastener comprises: a tissue contacting surface; a free
surface opposite the tissue contacting surface; and first and
second through bores, each extending from the tissue contacting
surface through the free surface.
30. A tissue fixation system as set forth in claim 29 wherein the
elongate fastener member is a suture including first and second
free ends and the suture is threadable through the first and second
through bores of the first fastener, such that first and second
free ends of the suture extend from the second tissue member
forming the second end of the elongate fastener member.
31. A tissue fixation system as set forth in claim 30 wherein the
second fastener comprises: a tissue contacting surface; a free
surface opposite the tissue contacting surface; and first and
second through bores, each extending from the tissue contacting
surface through the free surface, wherein the first free end of the
suture extends through the first through bore and the second free
end of the suture extends through the second through bore, wherein
the first and second through bores are affixable about the first
and second free ends of the suture.
32. A tissue fixation system as set forth in claim 30 wherein the
second fastener comprises: a tissue contacting surface; a free
surface opposite the tissue contacting surface; and a through bore
extending from the tissue contacting surface through the free
surface, wherein the first and second free ends of the suture
extend through the bore and the bore is affixable about the first
and second free ends of the suture.
33. A medical device for securing a fastener to an elongate member,
comprising: a handle; a tubular member including first and second
ends and defining a longitudinal passage along a central
longitudinal axis, wherein the first end is slidably disposed in
the handle; a tensioning mechanism disposed on the handle for
tensioning the elongate member; and a crimp mechanism disposed in
the first end on the tubular member for crimping the fastener about
the elongate member.
34. A medical device as set for the in claim 33, wherein the crimp
mechanism comprises: a collett positioned in the first end of the
tubular member and defining a collett passage longitudinally
aligned with the central longitudinal axis, wherein an end portion
of the collett is configured to receive the fastener; and an
elongate member tensioner slidably positioned in the handle and
operably connected to the collett, the elongate member tensioner
defining an elongate member passage longitudinally aligned with the
central longitudinal axis, wherein the elongate member tensioner is
movable along the central longitudinal axis from a first tension
position to a second tension position with respect to the
collett.
35. A medical device as set forth in claim 34, wherein the collett
includes first and second collett arms each having a force
application end portions which combine to form a fastener aperture,
wherein the fastener aperture is configured to receive the fastener
therein.
36. A medical device as set forth in claim 35, the crimp mechanism
further comprising a tension lever connected to the elongate member
tensioner and movable from a first lever position to a second lever
position with respect to handle such that the elongate member
tensioner is moved from the first tension position to the second
tension position.
37. A medical device as set forth in claim 36, wherein the tension
lever includes tension markings.
38. A medical device as set forth in claim 35, further comprising a
tension bias member, wherein the tension bias member biases the
elongated tension member into the first tension position.
39. A medical device as set forth in claim 35, wherein the elongate
member tensioner includes a circumferential groove.
40. A medical device as set forth in claim 39, wherein the crimping
mechanism comprising a collett closer affixed to the second end of
the tubular member, about the collett, wherein the tubular member
and the collett closer are a moveable from a first tube position to
a second tube position such that the collett closer compresses the
force application end portions of the first and second collett arms
about the fastener aperture.
41. A medical device as set forth in claim 40, further comprising a
trigger operably connected to the tubular member, the trigger
positionable from a first trigger position to a second trigger
position with respect to the handle, such that collett closer is
moved from the first tubular position to the second tubular
position.
42. A medical device as set forth in claim 41, further comprising a
trigger bias member, wherein the trigger bias member biases the
trigger into the first trigger position.
43. A medical device as set forth in claim 41, further comprising a
cutting mechanism disposed in the second end of the tubular member,
proximal to the collett, and operably connect to the trigger, such
that movement of the trigger from the second trigger position to a
third trigger position actuates the cutting mechanism.
Description
CROSS-REFERENCE TO RELATED APPLICATION
[0001] This Application claims the benefit of U.S. Provisional
Patent Application No. 60/655,140, filed Feb. 22, 2005, entitled
TISSUE FIXATION SYSTEM AND METHOD, the content of which is
incorporated by reference in its entirety.
FIELD OF THE INVENTION
[0002] The invention relates to a system and method for fixation
and stabilization of tissue. In particular, the invention relates
to minimally invasive bone fracture fixation and stabilization.
BACKGROUND OF THE INVENTION
[0003] It is well-known in the medical arts that applying pressure
to tissue helps during the healing process. Incised or torn soft
tissue, for example, may be approximated with bandages, sutures, or
staples. Proper and more rapid healing of broken or fractured bones
likewise may be facilitated by applying constant pressure to the
bone. For instance, physicians may insert pins, screws, or bolts in
the area of the fracture in order to apply pressure to the
fracture.
[0004] However, inserting screws through or around fractures can be
complex and time-consuming. For example, the process of inserting a
screw typically involves multiple steps conducted from multiple
incisions or openings that provide access to the treated bone or
tissue, including the steps of drilling holes, measuring the
relevant distances to determine the appropriate screw selection,
tapping the hole to establish threads, and screwing the screw into
the hole.
[0005] In addition to the length and complexity of the process,
bone screws also may lose their grip and strip out of the bone. In
addition, currently available lag screws also typically provide
only one side of cortex fixation and are generally not suited for
percutaneous surgery. Moreover, when placing the screws in the
bone, the physician may not accurately set the screw into the
distal hole or may miss the distal hole completely, thereby
resulting in the screw stripping the threads or breaking the
bone.
[0006] Many devices and instruments have been disclosed to fasten
soft and hard tissue for enhanced healing or tissue reconstruction.
Examples of such devices include bone plates, bone wraps, external
bone supports, and the like.
[0007] For example, U.S. Pat. No. 5,921,986, the contents of which
are incorporated herein by reference, discloses a bone suture and
associated methods for implantation and fracture fixation. The '986
Patent describes fasteners and anchors used in conjunction with an
elongate fixation element, such as a suture. In some cases, it may
be advantageous to use more rigid fixation elements.
[0008] Accordingly, a need exists for a tissue fixation instrument
which can provide flexible or rigid fixation of tissue while
accessing the tissue from a small skin portal.
SUMMARY OF THE INVENTION
[0009] The present invention relates to a tissue fixation system.
The system comprises an elongate fastening member and a fastener
moveable with respect to the elongate fastening member from a first
orientation to a second orientation, the fastener having a body
with a tissue contacting surface that includes a groove configured
and dimensioned to receive a portion of the elongate member in the
first orientation. The system can also include a second fastener or
other means for maintaining tension in the elongate fastening
member.
[0010] A biasing means can be provided to maintain the fastener in
the first orientation. The biasing means can be an adhesive between
the groove and the portion of the elongate fastening member
received in the groove. The biasing means could also be a frangible
connection between the groove and the portion of the elongate
fastening member received in the groove.
[0011] The fastener body can have a free surface opposite the
tissue contacting surface, with the free surface including a
channel configured and dimensioned to receive a portion of the
elongate member in the first orientation. The fastener body can
also include a through bore extending from the tissue contacting
surface through the free surface.
[0012] In one embodiment, the fastener body includes leading and
trailing ends. The leading end can be tapered or otherwise shaped
to facilitate insertion. The groove terminates at the through bore
and extends toward one of the leading and trailing ends and the
channel terminates at the through bore and extends toward the other
of the leading and trailing ends. In an exemplary embodiment, the
groove extends toward the leading end and the channel extends
toward the trailing end.
[0013] The free surface of the fastener body can be provided with a
well surrounding the through bore. The well can be configured and
dimensioned to receive at least a portion of the stop. A distal end
of the elongate fastening member can include a stop larger than the
through bore.
[0014] The present invention also relates to a medical instrument
or device for securing the fastener with respect to the elongate
fastening member. The medical device tensions the elongate
fastening member and crimps either the fastener or a bushing.
Another aspect of the invention relates to methods of tissue
fixation using the disclosed tissue fixation systems.
BRIEF DESCRIPTION OF THE DRAWINGS
[0015] A more complete understanding of the present invention, and
the attendant advantages and features thereof, will be more readily
understood by reference to the following detailed description when
considered in conjunction with the accompanying drawings
wherein:
[0016] FIG. 1 shows a schematic illustration of a tissue fixation
system according to the present invention utilized for fracture
fixation;
[0017] FIG. 2 shows a perspective view of a fastener according to
the present invention;
[0018] FIG. 3 shows a side view of the fastener of FIG. 2;
[0019] FIG. 4 shows a bottom view of the fastener of FIG. 2;
[0020] FIG. 5 shows a top view of the fastener of FIG. 2;
[0021] FIG. 6 shows a fastener and elongate fastening member with
the fastener in a first orientation with respect to the elongate
fastening member;
[0022] FIG. 7 shows a front view of a fastener in the first
orientation with respect to the elongate fastening member with the
fastener rotated 180.degree. compared to FIG. 6;
[0023] FIG. 8 shows a back view of the fastener and elongate
fastening member of FIG. 7;
[0024] FIG. 9A shows an elongate fastening member according to the
present invention;
[0025] FIG. 9B shows an elongate fastening member including
expandable members;
[0026] FIG. 10 shows a fastener in a second orientation with
respect to an elongate fastening member;
[0027] FIG. 11 shows a cannulated drill system used to create a
passage through the tissue to be fixed;
[0028] FIG. 12 shows a sleeve having a lumen through which the
fixation system can be passed;
[0029] FIG. 13 shows a distal fastener being inserted into the
sleeve;
[0030] FIG. 14 shows a pushrod used to move the distal fastener
through the sleeve;
[0031] FIG. 15 shows the distal fastener in the second
orientation;
[0032] FIG. 16 shows a proximal fastener being used to maintain the
tension in the elongate fastening member;
[0033] FIG. 17 depicts a front isometric view of the medical device
of the present invention;
[0034] FIG. 18 depicts a rear partial isometric view showing the
tensioning mechanism of the medical device of FIG. 17;
[0035] FIG. 19 depicts a rear isometric view showing the tensioning
mechanism of the medical device of FIG. 17;
[0036] FIG. 20 depicts an isometric view of the crimping mechanism
collett of the medical device of FIG. 17;
[0037] FIG. 21 depicts a partial isometric view showing the handle
portion of the crimping mechanism of the medical device of FIG.
17;
[0038] FIG. 22 depicts a top sectional view of the crimping
mechanism collett closer of the medical device of FIG. 17;
[0039] FIG. 23 depicts a partial isometric view showing the cutting
mechanism of the medical device of FIG. 17;
[0040] FIG. 24 depicts a partial isometric view showing the collett
portion of the cutting mechanism of FIG. 23;
[0041] FIG. 25 depicts an isometric view showing the cutting arm of
the cutting mechanism of FIG. 24;
[0042] FIG. 26 depicts the medical device of FIG. 17 in use to
secure a bone fracture;
[0043] FIG. 27 depicts a front isometric view of an alternative
medical device of the present invention;
[0044] FIG. 28 depicts an isometric view of the crimping mechanism
collett of the medical device of FIG. 27;
[0045] FIG. 29 depicts an isometric view of the crimping mechanism
collett closer of the medical device of FIG. 27;
[0046] FIG. 30 depicts a sectional view of the medical device of
FIG. 27 in use to secure a bone fracture;
[0047] FIG. 31 depicts an exemplary fastener for use with the
medical device of FIG. 27;
[0048] FIG. 32 depicts an alternative sectional view of the medical
device of FIG. 27 in use to secure a bone fracture;
[0049] FIG. 33 depicts an alternative fastener for use with the
medical device of FIG. 32;
[0050] FIG. 34 depicts an alternative cable tensioner for the
medical device of FIG. 17;
[0051] FIG. 35 depicts a sectional view of the cable tensioner of
FIG. 34;
[0052] FIG. 36 depicts a front isometric view of the medical device
of the present invention;
[0053] FIG. 37 depicts a side sectional view showing the tensioning
mechanism of the medical device of FIG. 36;
[0054] FIG. 38 depicts a rear exploded view showing the tensioning
mechanism of the medical device of FIG. 36;
[0055] FIG. 39 depicts an isometric view of the crimping mechanism
collett of the medical device of FIG. 36;
[0056] FIG. 40 depicts a partial isometric view showing the handle
portion of the crimping mechanism of the medical device of FIG.
36;
[0057] FIG. 41 depicts a partial isometric view showing the cutting
mechanism of the medical device of FIG. 36;
[0058] FIG. 42 depicts an isometric view of the cutting mechanism
in the collett of the medical device of FIG. 36;
[0059] FIG. 43 depicts the cutting wedge of the medical device of
FIG. 36; and
[0060] FIG. 44 depicts a safety lock of the medical device of FIG.
36.
DETAILED DESCRIPTION OF THE INVENTION
[0061] The present invention provides a tissue fixation system for
dynamic and rigid fixation of tissue. The system can be utilized
for the fixation and stabilization of body tissue, including soft
tissue to soft tissue, soft tissue to bone, and bone to bone. The
surgical system can additionally be used to affix implants and
grafts to body tissue. The system can access and treat fractured,
incised or torn tissue, or the like, from one access area (i.e.,
from only one opening to the tissue to be fastened) instead of
requiring two or more openings. That is, the system is a linear
fixation system that can be used with a single, small incision or
portal in the skin or other soft tissue to gain access to the
fractured bone. The fixation system may be an all-in-one system,
packaged as a system kit, for creating a passage in tissue,
positioning fasteners, and tensioning an elongate fastening member,
like a suture, thread, cable, wire, rod, or pin. The individual
components of the system can either be reusable or single use
components.
[0062] Referring now to the drawing figures in which like reference
designators refer to like elements, FIG. 1 shows an exemplary
embodiment of a tissue fixation system 100 according to the present
invention. A fractured portion 102 of a bone 104 is approximated by
system 100. Use of system 100 is not limited to any particular type
of fracture. Furthermore, use of system 100 is not limited to
fracture fixation. In other words, system 100 can be utilized for
other tissue fixation applications (such as soft tissue) or similar
clinical indications. Examples of such tissue includes, are not
limited to, muscle, cartilage, ligament, tendon, skin, etc. Also,
the tissue may be stomach tissue, and the system may be used during
bariatric surgery, like stomach stapling. Additionally, the system
100 can be used for the fixation of implants to tissue.
[0063] In this regard, the present invention may be used in
conjunction with any surgical procedure of the body. The repair,
reconstruction, augmentation, and securing of tissue or an implant
may be performed in connection with surgery of a joint, bone,
muscle, ligament, tendon, cartilage, capsule, organ, skin, nerve,
vessel, or other body part. For example, tissue may be repaired,
reconstructed, augmented, and secured following intervertebral disc
surgery, knee surgery, hip surgery, organ transplant surgery,
bariatric surgery, spinal surgery, anterior cruciate ligament (ACL)
surgery, tendon-ligament surgery, rotator cuff surgery, capsule
repair surgery, fractured bone surgery, pelvic fracture surgery,
avulsion fragment surgery, hernia repair surgery, and surgery of an
intrasubstance ligament tear, annulus fibrosis, fascia lata, flexor
tendons, etc. In one particular application, an anastomosis is
performed over a balloon and the methods and devices of the present
invention are used to repair the vessel.
[0064] Also, tissue may be repaired after an implant has been
inserted within the body. Such implant insertion procedures
include, but are not limited to, partial or total knee replacement
surgery, hip replacement surgery, bone fixation surgery, etc. The
implant may be an organ, partial organ grafts, tissue graft
material (autogenic, allogenic, xenogenic, or synthetic), collagen,
a malleable implant like a sponge, mesh, bag/sac/pouch, collagen,
or gelatin, or a rigid implant made of metal, polymer, composite,
or ceramic. Other implants include breast implants, biodegradable
plates, porcine or bovine patches, metallic fasteners, compliant
bearing for medial compartment of the knee, nucleus pulposus
prosthetic, stent, tissue graft, tissue scaffold, biodegradable
collagen scaffold, and polymeric or other biocompatible scaffold.
The scaffold may include fetal cells, stem cells, embryonal cells,
enzymes, and proteins.
[0065] The present invention further provides flexible and rigid
fixation of tissue. Both rigid and flexible fixation of tissue
and/or an implant provides compression to enhance the healing
process of the tissue. A fractured bone, for example, requires the
bone to be realigned and rigidly stabilized over a period time for
proper healing. Also, bones may be flexibly secured to provide
flexible stabilization between two or more bones. Soft tissue, like
muscles, ligaments, tendons, skin, etc., may be flexibly or rigidly
fastened for proper healing. Flexible fixation and compression of
tissue may function as a temporary strut to allow motion as the
tissue heals. Furthermore, joints which include hard and soft
tissue may require both rigid and flexible fixation to enhance
healing and stabilize the range of motion of the joint. Flexible
fixation and compression of tissue near a joint may provide motion
in one or more desired planes. The fasteners described herein and
incorporated by reference provide for both rigid and flexible
fixation.
[0066] Although the invention is described primarily on a
macroscopic level, it is also envisioned that the present invention
can be used for microscopic applications. For example, in the
repair of nerve tissue, individual cells or fibers may need to be
repaired. Similarly, muscle repair may require tightening of
individual muscle fibers.
[0067] System 100 includes a distal fastener 106 contacting
fracture portion 102, a proximal fastener 108 contacting bone 104,
and an elongate fastening member 110 extending through the fracture
and coupling distal and proximal fasteners 106, 108. Tension is
maintained in elongate fastening member 110 to press fasteners 106,
108 against opposite sides of bone 104 with a desired force. This
force presses fracture portion 102 against bone 104 firmly together
to promote healing of the fracture. If desired, buttons or other
force distributing members could be provided between fasteners 106,
108 and the bone. Although FIG. 1 shows distal and proximal
fasteners 106, 108 as having the same construction, they could have
differing construction. However, for convenience and practical
purposes, it may be beneficial if distal and proximal fasteners 106
and 108 have substantially the same construction.
[0068] FIGS. 2-5 show an exemplary embodiment of a fastener 112
that can be used as part of system 100, i.e. as either or both of
distal and proximal fasteners 106, 108. Fastener 112 has a body 114
that is configured and dimensioned to facilitate implantation
through minimally invasive procedures, e.g. through a cannula or
sleeve. In particular, body 114 includes a tissue contacting
surface 116 that is provided with groove 118 that receives a
portion of elongate fastening member 110 when fastener 112 is in a
first orientation with respect to elongate fastening member 110.
This is seen in FIG. 6. The accommodation of elongate fastening
member 110 within groove 118 helps to minimize the profile of the
assembly of fastener 112 and elongate fastening member 110. The
reduced profile can be more readily passed through a cannula or
sleeve. If desired, an adhesive can be provided within groove 118
to bias fastener 112 in the first orientation. Alternatively, a
frangible connection can be provided between groove 118 and the
portion of elongate fastening member 110. This frangible connection
keeps fastener 112 in the first orientation with respect to
elongate fastening member 110 until it is broken.
[0069] Fastener 112 is provided with first and second ends 120,
122. As shown in FIG. 6, first end 120 is the leading end and
second end 122 is the trailing end. In this position, when fastener
112 is pivoted to a second orientation, like distal fastener 106 of
FIG. 1, tissue contacting surface 116 is in contact with the
tissue. As shown in FIGS. 7 and 8, second end 122 is the leading
end and first end 120 is the trailing end. In this position, when
fastener 112 is pivoted to the second orientation, like proximal
fastener 108 of FIG. 1, tissue contacting surface 116 is in contact
with the tissue.
[0070] Fastener body 114 has a free surface 124 opposite tissue
contacting surface 116. Free surface 124 is provided with a channel
126 that receives a portion of elongate fastening member 110 when
fastener 112 is in a first orientation with respect to elongate
fastening member 110. As shown in FIGS. 7 and 8, fastener 112 is
being slid along elongate fastening member 110. In particular, a
through bore 128 extends from tissue contacting surface 116 through
free surface 124. Through bore 128 is larger in diameter than
elongate fastening member 110 so that fastener 112 freely slides
along elongate fastening member 110. A portion of elongate
fastening member 110 fits within channel 126 on free surface 124
and a portion of elongate fastening member 110 fits within groove
118 on tissue contacting surface 116.
[0071] Fastener body 114 is shown with first end 120 having a
substantially flat profile and second end 122 having a tapered
profile. In general, any suitable external configuration can be
used for fastener 112. Examples of fasteners may be found in U.S.
Pat. Nos. 5,163,960; 5,403,348; 5,464,426; 5,549,630; 5,593,425;
5,713,921; 5,718,717; 5,782,862; 5,814,072; 5,814,073; 5,845,645;
5,921,986; 5,948,002; 6,010,525; 6,045,551; 6,159,234; 6,368,343;
6,447,516; 6,475,230; 6,592,609; 6,635,073; and 6,719,765. Other
fastener types are disclosed in U.S. patent application Ser. Nos.
10/102,413; 10/228,855; 10/779,978; 10/780,444; and 10/797,685. The
above cited patents and patent applications are hereby incorporated
by reference.
[0072] Fastener 112 can be made of any biocompatible material
suitable for a given application. For example, the fasteners may
be, but are not limited to, degradable, biodegradable, bioerodible,
bioabsorbable, mechanically expandable, hydrophilic, bendable,
deformable, malleable, riveting, threaded, toggling, barbed,
bubbled, laminated, coated, blocking, pneumatic, one-piece,
multi-component, solid, hollow, polygon-shaped, pointed,
self-introducing, and combinations thereof. Also, the fasteners may
include metallic material, polymeric material, ceramic material,
composite material, body tissue, synthetic tissue, hydrophilic
material, expandable material, compressible material, heat bondable
material, and combinations thereof. Examples of body tissue include
bone, collagen, cartilage, ligaments, or tissue graft material like
xenograft, allograft, and autograft. The fasteners may also be made
from a porous matrix or mesh of biocompatible and bioresorbable
fibers acting as a scaffold to regenerate tissue.
[0073] The fasteners may further be made of or have a coating made
of an expandable material. The material could be compressed then
allowed to expand. Alternatively, the material could be hydrophilic
and expand when it comes in contact with liquid. Examples of such
expandable materials are ePTFE and desiccated body tissue.
[0074] Moreover, the fasteners described herein and incorporated by
reference may include therapeutic substances to promote healing.
These substances could include antibiotics, hydroxyapatite,
anti-inflammatory agents, steroids, antibiotics, analgesic agents,
chemotherapeutic agents, bone morphogenetic protein (BMP),
demineralized bone matrix, collagen, growth factors, autogenetic
bone marrow, progenitor cells, calcium sulfate, immo suppressants,
fibrin, osteoinductive materials, apatite compositions, germicides,
fetal cells, stem cells, enzymes, proteins, hormones, cell therapy
substances, gene therapy substances, and combinations thereof.
These therapeutic substances may be combined with the materials
used to make the fasteners to produce a composite fastener.
Alternatively, the therapeutic substances may be impregnated or
coated on the fastener. Time-released therapeutic substances and
drugs may also be incorporated into or coated on the surface of the
fastener. The therapeutic substances may also be placed in a
bioabsorbable, degradable, or biodegradable polymer layer or
layers.
[0075] FIG. 9A shows an exemplary embodiment of an elongate
fastening member 130. Elongate fastening member 130 includes a body
132 and has a stop 134 at a distal end. Body 132 can be selected
for a given application. For example, if a rigid elongate fastening
member 130 is needed, body 132 can be a rod or a tube. If a more
flexible elongate fastening member 130 is needed, body 132 can be a
suture. In general, a wire analogous to those used for cerclage of
bone fractures is believed to provide a suitable combination of
strength and flexibility. Although body 132 is shown as a single
strand wire, the invention can be used with any type of surgical
cable, such as a multi-strand cable.
[0076] Stop 134 can be made integral with body 132 or separate and
then attached. Stop 134 is larger in diameter than through bore 128
in body 114 of fastener 112. Thus, once stop 134 reaches through
bore 128, fastener 112 cannot be slid any further along elongate
fastening member 130. As shown in FIG. 5, free surface 124 of
fastener 112 is provided with a well 136 surrounding through bore
128. Well 136 is configured and dimensioned to receive at least a
portion of stop 134. As shown in FIG. 10, this helps reduce the
profile of the assembly when fastener 112 is in a second
orientation with respect to elongate fastening member 130.
[0077] Referring to FIG. 9B, in another embodiment, the elongated
fastener member 130 includes expandable members 131, positioned
along the body 132. Upon insertion into the tissue, the expandable
members 131 expand to engage the surrounding tissue. For examples,
the expandable members 131 can be barbs. The barbs 131 engage the
surrounding tissue, maintaining the elongated fastener member's 130
position within the tissue.
[0078] The elongate fastening members of the present invention may
be made of metallic material, non-metallic material, composite
material, ceramic material, polymeric material, co polymeric
material, or combinations thereof. The members may be degradable,
biodegradable, bioabsorbable, or nonbiodegradable. Examples of
suture materials that can be used for the elongate fastening
members are polyethylene, polyester, cat gut, silk, nylon,
polypropylene, linen, cotton, and copolymers of glycolic and lactic
acid. Preferably, the members are flexible or bendable. They may be
threadlike, monofilament, multifilament, braided, or interlaced.
The members may have a coating of therapeutic substances or drugs.
For example, the members may include antibiotics, hydroxyapatite,
anti-inflammatory agents, steroids, antibiotics, analgesic agents,
chemotherapeutic agents, bone morphogenetic protein, demineralized
bone matrix, collagen, growth factors, autogenetic bone marrow,
progenitor cells, calcium sulfate, immo suppressants, fibrin,
osteoinductive materials, apatite compositions, fetal cells, stem
cells, enzymes, proteins, hormones, and germicides.
[0079] The use of the tissue fixation system according to the
present invention will now be described using fracture fixation as
an example. If necessary, the fracture is reduced bringing fracture
portion 102 into contact with bone 104 (FIG. 11). The reduction can
be achieved using any number of techniques.
[0080] As also shown in FIG. 11, a drill system 138 is used to
drill across the fracture, thereby creating a passage completely
through bone 104. Drill system 138 includes a drill bit 140 with a
headpiece configured for attachment to a drill. A drill stop can be
placed on the headpiece and prevents drill bit 140 from penetrating
too far beyond the tissue to be drilled. Drill system 138 may be a
cannulated drill system that fits over a k-wire or other similar
guide wire. A cannula or sleeve 142 may encircle drill bit 140 or
at least the shaft portion of drill bit 140. As drill bit 140
creates a passage through bone 104, sleeve 142 is positioned in the
passage. Drill system 138 is used to create a passage in bone 104
from the proximal side of bone 104 to the distal side of bone 104,
then the drill and drill bit 140 are removed from sleeve 142 (FIG.
12).
[0081] As shown in FIG. 13, a distal fastener 112a is inserted into
sleeve 142. Distal fastener 112a is inserted in the first
orientation with respect to elongate fastening member 130 with
first end 120 as the leading end. In this configuration, tissue
contacting surface 116 will be in contact with fracture portion 102
when distal fastener 112a is pivoted into the second orientation.
This is best seen in FIGS. 14 and 15, in which a pushrod 144 is
used to advance distal fastener 112a and elongate fastening member
130 through sleeve 142. Pushrod 144 also facilitates the pivoting
of distal fastener 112a from the first orientation to the second
orientation. This pivoting is not possible until distal fastener
112a has exited through sleeve 142. Also, since the length of
distal fastener 112a is larger than the passage created in bone
104, pulling back on elongate fastening member 130 helps to ensure
distal fastener 112a is in the second orientation and flush against
fracture portion 102.
[0082] As illustrated in FIG. 16, sleeve 142 is removed from bone
104. Fastener 112a is located on the distal side of bone 104.
Elongate fastening member 130 extends from fastener 112a through
the bone passage and out the proximal opening of the bone or tissue
passage. Any suitable means can be used to keep distal fastener
112a against fracture portion 102 with tension, where the tension
can be measure and controlled in accordance with use. For example,
elongate fastening member 130 can be deformed at the proximal end
of the passage such that the deformed section rests against bone
104. The deformation would depend on the nature of elongate
fastening member 130. If elongate fastening member 130 is a
relatively flexible element, such as a suture, cable, or wire, then
simply tying a knot in fastening member 130 could be sufficient to
maintain the tension. If elongate fastening member 130 does not
allow a knot, such as would be the case with a rod or tube, then
mechanical deformation of elongate fastening member 130 to create
an enlarged head could be sufficient to maintain the tension. U.S.
Patent Application Publication No. US 2002/0016593, the contents of
which are incorporated herein by reference, discloses mechanisms to
mechanically deform an extension member and could be used to deform
elongate fastening member 130.
[0083] Alternatively, the elongated fastening member 130 can be
deformed by an energy, such as thermal energy, to deform elongate
fastening member 130 to create an enlarged head sufficient to
maintain the tension.
[0084] In an exemplary embodiment, a proximal fastener 112b is used
to secure distal fastener 112a and elongate fastening member 130.
In this embodiment, proximal fastener 112b is identical to distal
fastener 112a. If not already pre-loaded, proximal fastener 112b is
loaded onto elongate fastening member 130. Proximal fastener 112b
is loaded as shown in FIGS. 7 and 8, i.e. with second end 122 as
the leading end so that after proximal fastener 112b is slid down
against bone 104 and pivoted into the second orientation, tissue
contacting surface 116 is in contact with bone 104.
[0085] Elongate fastening member 130 is tensioned, and proximal
fastener 112b is secured to elongate fastening member 130 to
thereby approximate the fracture and stabilize bone 104. The
tension of elongate fastening member 130 pulls on distal and
proximal fasteners 112a, 112b generally toward each other, thereby
applying pressure to the fractured bone or tissue. In this regard,
a bushing 146 can be used to secure proximal fastener 112b with the
desired tension. Single or multiple elongated members 130 can be
used to secure the fractured bone or tissue.
[0086] Although a number of mechanisms can be used to secure
bushing 146, an instrument or medical device particularly useful
for this will now be described.
[0087] In this regard, the present invention also provides a
medical device for securing a fastener against relative movement
with respect to a cable. As previously disclosed, a cable and pair
of oppositely spaced fasteners can be used to secure a bone
facture. The cable is passed through the bone and fracture; a first
fastener secures the cable on a first side (fracture side) of the
bone; and a second fastener is positioned about the cable on a
second side of the bone, opposite the first fastener. A bushing is
positioned onto the cable to secure the second fastener against the
second side of the bone. A force is applied to the bushing,
compressing the second fastener against the second side of the bone
and providing a tension to the cable. The tension in the cable can
be measured and controlled, for example, with the used of a sensor
and spring element. The spring can apply the force to tension the
cable, and the sensor can be used to measure the resulting tension.
Alternatively, the sensor can measure the compression of the tissue
to determine the tension. The bushing is crimped about the cable,
securing the second fastener against the second side of the bone,
such that a tension is provided through the cable between the first
and second fasteners.
[0088] Referring to FIG. 17, a medical device 200 is provided for
securing the bushing to the cable. The medical device 200 includes
a handle portion 202 having a tensioning mechanism 204, tensioning
the cable and applying a force to the bushing, and a crimping
mechanism 206 for securing the bushing to the cable.
[0089] Referring also to FIGS. 18 and 19, the tensioning mechanism
204 includes a collett holder 208 defining a longitudinal passage
along a central longitudinal axis A. The collett holder 208 is
affixedly positioned through a top portion 212 of the handle
portion 202 with collett holder pin 214. A cable tensioner 216 is
slidably positioned on a first end 218 of the collett holder 208.
The cable tensioner 216 defines a cable passage longitudinally
aligned with the longitudinal passage of the collett holder 208. An
end portion 222 of the cable tensioner 216 includes a cable
aperture 224 for threading the cable there through. A radial groove
226 and circumferential groove 228 are provided on the end portion
222 of the cable tensioner 216, such that the cable can be wrapped
about the circumferential groove 228 of the cable tensioner 216,
thereby preventing relative movement between the cable and the
cable tensioner 216.
[0090] A cable tension lever 230 is pivotally connected to the
cable tensioner 216 with a lever pin 232. The cable tension lever
230 is adjustably positioned on the handle portion 202 with body
pins 234, wherein a body pin 234 is mirrorly positioned on opposite
sides of the handle portion 202. The body pins 234 are engaged in
the cable tension lever 230 arcuate lever slots 236, such that
cable tension lever 230 and cable tensioner 216 are movably
connected to the handle portion 202.
[0091] In use, as the cable tension lever 230 is pivoted about the
cable tensioner 216 from a first lever position L1 to a second
lever position L2, the body pins 234 traverse the arcuate lever
slots 236, resulting in a translation of the cable tensioner 216
along the first end 218 of the collett holder 208 from a first
tensioner position T1 to a second tensioner position T2. A tension
bias member 238 is interposed between the cable tensioner 216 and
the handle portion 202, biasing the cable tensioner 216 into the
first tensioner position T1. The cable tension lever 230 includes
tension indicating markings 240 along each of the arcuate lever
slots 236. The tension markings 240 indicate the tension to be
applied to the cable.
[0092] Referring also to FIG. 34 an alternative cable tensioner 440
is provided. Cable tensioner 440 is slidably positioned on a first
end 218 of the collett holder 208. The cable tensioner 440 defines
a cable passage longitudinally aligned with the longitudinal
passage of the collett holder 208. An end portion 442 of the cable
tensioner 440 includes a cleat 444 and a cleat stop 446. The cleat
444 is pivotally mounted to the cable tensioner 440, including a
bias member 448 biasing the cleat 444 into a closed position. A
cable 450 is threadable between the cleat 446 and the cleat stop
448, where in the closed position the cleat 446 imparts a force
onto the cable 450, securing the cable 450 in the cable tensioner
440.
[0093] The bias member 448 biases the cleat 444 such that in the
closed position the cable can be further drawn through the cable
tensioner 440, for example, to position the fastener proximal to
the tissue while removing any initial slack from the cable 450.
However, the cleat 444 prevents the cable 450 from being drawn back
through the cable tensioner 440. For example, the cleat 444 can
include an arcuate contact surface 452 such that the force imparted
on the cable 450 in the closed position increases as the tension on
the cable 450 increases, preventing the cable 450 from being drawn
back through the cable tensioner 440. The cleat arcuate surface 452
can further include a plurality of teeth 454, which can be utilized
to grip cable 450.
[0094] Referring to FIGS. 18 and 20, a collett 242 is affixed to a
second end portion 244 of the collett holder 208, opposite the
cable tensioner 216. The collett 242 defines a collett passage
longitudinally aligned with the longitudinal passage of the collett
holder 208 along the central longitudinal axis A. An end portion of
the collett 242 is bisected, forming first and second collett arms
248 and 250. A gap portion 252 is provided between the first and
second collett arms 248 and 250. Each of the first and second
collett arms 248 and 250 includes force application end portions
254 and 256. The force application end portions 254 and 256 combine
to form a bushing aperture 258 configured to received the bushing
therein. The collett 242 is made of a semi-rigid material, such
that the first and second collett arms 248 and 250 can be moved
from an open to a closed position, closing the gap 252 between the
force application end portions 254 and 256.
[0095] In use, the tensioning mechanism 204 is used to tension the
cable. The cable can include a single or multiple filaments. The
cable is inserted through the medical device 200 along the central
longitudinal axis A, through the collett 242, collett holder 208,
and the cable tensioner 216, positioning the bushing in the bushing
aperture 258 and extending the cable through the cable aperture
224. To tension the cable, the cable tension lever 230 is actuated
from the first lever position L1 to the second lever position L2,
sliding the cable tensioner 216 along the collett holder 208 from
the first tensioner position T1, into the handle portion 202
against the tension bias member 238, to the second tensioner
position T2. The cable is positioned through the radial groove 226
and wrapped about the circumferential groove 228 on the end portion
222 of the cable tensioner 216, securing the cable to the cable
tensioner 216. The cable tension lever 230 is released, such that
tension bias member 238 biases the cable tensioner 216 from the
second tensioner position T2 towards the first tensioner position
T1. The movement of the cable tensioner 216 towards the first
tensioner position T1 applies a tension to the cable, forcing the
bushing into the second fastener. The applied tension can be
selected by actuating the cable tension lever 230 to the desired
tension marking 240.
[0096] Referring again to FIGS. 17 and 21, the crimping mechanism
206 includes an outer tube 260 slidingly positioned over the
collett holder 208. The outer tube 260 includes a first end 262
operably connected to a trigger 264 and a second end 266 connected
to a collett closer 268. The trigger 264 is pivotally mounted in
the handle portion 202, such that the trigger 264 can be actuated
from a first trigger position TR1 to a second trigger position TR2.
A locking mechanism 265 prevents the trigger 264 from being
actuated. The locking mechanism 265 is rotated to disengage the
trigger 264, allowing actuation of the trigger 264.
[0097] The operable connection between the first end of the outer
tube 262 and the trigger 264 includes an outer tube ferrule 270
slidably positioned about the collett holder 208 and affixed to the
first end of the outer tube 262. A tube bias member 272 is
interposed between the handle portion 202 and the outer tube
ferrule 270, such that the tube bias member 272 biases the outer
tube ferrule 270 and the outer tube 260 into a first tube position
P1. A pair of crimp cams 274 are pivotally connected to the handle
portion 202 on opposite sides of the trigger 264. The crimp cams
274 each include first edges 276 having an arcuate section 278 for
engaging the outer tube ferrule 270, where the crimp cams 274 are
translatable with respect to the handle portion 202 from a first
cam position C1 to a second cam position C2.
[0098] An actuation of the trigger 264 from a first trigger
position TR1 to a second trigger position TR2 translated the crimp
cams 274 with respect to the handle portion from a first cam
position C1 to a second cam position C2 position. The arcuate
sections 278 of the crimp cams 274 engage the outer tube ferrule
270, translating the outer tube ferrule 270 and the outer tube 260
along the collett holder 208 from the first tube position P1 to a
second tube position P2. As the trigger 264 is released, the tube
bias member 272 biases the outer tube ferrule 270 and the outer
tube 260 from the second tube position P2 to the first tube
position P1. Simultaneously, the crimp cams 274 and the trigger 264
are moved to the first cam position C1 and the first trigger
position TR1.
[0099] Referring to FIGS. 17 and 22, the collett closer 268 is
positioned on the outer tube 260 proximal to the force application
end portions 254 and 256 of the first and second collett arms 248
and 250. As the outer tube 260 is moved from the first tube
position P1 to the second tube position P2, the collett closer 268
is moved over the force application end portions 254 and 256. The
collett closer 268 includes inner tapered surfaces 280, such that
the inner tapered surfaces 280 apply compressive forces to the
force application end portions 254 and 256 as the collett closer
268 is moved over the force application end portions 254 and 256,
closing the gap 252 there between.
[0100] In use, the trigger 264 is actuated from the first trigger
position TR1 to the second trigger position TR2. The actuation of
the trigger 264 slides the outer tube 260 along the collett holder
208 from the first tube position P1 to the second tube position P2,
moving collett closer 268 about the force application end portions
254 and 256 of the first and second collett arms 248 and 250. The
inner tapered surfaces 280 of the collett closer 268 apply
compressive forces to the first and second force application end
portions 254 and 256, closing the gap 252 there between. The
trigger 264 is released, allowing the tube bias member 272 to bias
the outer tube 260 from the second tube position P2 to the first
tube position P1, moving the collett closer 268 from the force
application end portions 254 and 256.
[0101] Referring to FIGS. 23-25, the crimping mechanism 206 can
further include a cutting mechanism. The cutting mechanism includes
a cut off cam 284 slidingly positioned along a bottom portion of
the collett holder 208. The cut off cam 284 includes a first end
portion 286 positioned through the outer tube ferrule 270. A cut
off cam ring 288 is slidably positioned about the collett holder
208, engaging the first end portion 286 of the cut off cam 284. The
cut off cam ring 288 is positioned proximal to the trigger 264,
such that as the trigger 264 is actuated from the first trigger 264
position TR1 to the second trigger 264 position TR2, a top portion
290 of the trigger 264 engages the cut off cam ring 288, sliding
the cut off cam ring 288 and cut off cam 284 along the collett
holder 208. A cut off bias member 291 is interposed between the
outer tube ferrule 270 and the cut off cam ring 288.
[0102] A cut off arm 292 is connected to the collett 242, at least
partially positioned in the gap 252 between the first and second
collett arms 248 and 250. The cut off arm 292 includes a cutting
head portion 294 positioned proximal to the first and second force
application end portions 254 and 256, at least partially positioned
in the gap 252, interposed between the first and second collett
arms 248 and 250. The cutting head portion 294 includes a cutting
edge 296, for cutting the cable, and a lower angular surface 298
for engagement by a second end portion 300 of the cut off cam
284.
[0103] In use, the trigger 264 is actuation from the first trigger
position TR1 to the second trigger position TR2. The actuation of
the trigger 264 results in the top portion 290 of the trigger 264
engaging the cut off cam ring 288, sliding the cut off cam ring 288
and cut off cam 284 along the collett holder 208. The second end
portion 300 of the cut off cam 284 engages the angular surface 298
of the cutting head 294, forcing the cutting edge 296 into the
cable, cutting the cable. The trigger 264 is released, allowing the
cut off bias member 291 to bias the cut off cam 284 from the
cutting head 294.
[0104] Referring to FIG. 26, in a method of use, the cable is
passed through the bone and fracture, where a first fastener
secures the cable on a first side (fracture side) of the bone and a
second fastener is positioned about the cable on a second side of
the bone, opposite the first fastener. A bushing is positioned onto
the cable to secure the second fastener against the second side of
the bone.
[0105] The cable is inserted through the medical device 200 along
the central longitudinal axis "A", through the collett 242, collett
holder 208, and the cable tensioner 216, positioning the bushing in
the bushing aperture 258 and extending the cable through the cable
aperture 224. To tension the cable, the cable tension lever 230 is
actuated from the first lever position L1 to the second lever
position L2, sliding the cable tensioner 216 along the collett
holder 208 from the first tensioner position T1, into the handle
portion 202 against the tension bias member 238, to the second
tensioner position T2. The cable is positioned through the radial
groove 226 and wrapped about the circumferential groove 228 on the
end portion 222 of the cable tensioner 216, securing the cable to
the cable tensioner 216. The cable tension lever 230 is released,
such that tension bias member 238 biases the cable tensioner 216
from the second tensioner position T2 towards the first tensioner
position T1. The movement of the cable tensioner 216 towards the
first tensioner position T1 applies a tension to the cable,
pressing the bushing against the second fastener. The applied
tension can be selected by actuating the cable tension lever 230 to
the desired tension marking 240.
[0106] The trigger 264 is actuated from the first trigger position
TR1 to the second trigger position TR2. The actuation of the
trigger 264 slides the outer tube 260 along the collett holder 208
from the first tube position P1 to the second tube position P2,
moving collett closer 268 about the force application end portions
254 and 256 of the first and second collett arms 248 and 250. The
inner tapered surfaces 280 of the collett closer 268 apply
compressive forces to the first and second force application end
portions 254 and 256, compressing the first and second force
application end portions 254 and 256 about the bushing positioned
in the bushing aperture 258. The compressive forces crimp the
bushing about the cable, securing the bushing to the cable.
[0107] Simultaneously, the actuation of the trigger 264 results in
the top portion 290 of the trigger 264 engaging the cut off cam
ring 288, sliding the cut off cam ring 288 and cut off cam 284
along the collett holder 208. The second end portion 300 of the cut
off cam 284 engages the angular surface 298 of the cutting head
294, forcing the cutting edge 296 into the cable, cutting the
cable.
[0108] In another embodiment a medical device 320 of the present
invention secures a fastener against relative movement with respect
to a suture, with the fastener itself being deformed. Medical
device 320 is substantially similar to medical device 200 and like
reference number shall be used to indicate like items.
[0109] Referring to FIGS. 27 and 28, medical device 320 includes
collett 322. As with collett 242, previously disclosed and
illustrated, collett 322 is affixed to the second end portion 244
of the collett holder 208, opposite the cable tensioner 216. The
collett 322 defines a collett passage longitudinally aligned with
the longitudinal passage of the collett holder 208, along the
central longitudinal axis A. An end portion of the collett 322 is
bisected, forming first and second collett arms 324 and 326. A gap
portion 328 is provided between the first and second collett arm
324 and 326. Each of the first and second collett arms 324 and 326
includes force application end portions 330 and 332. The force
application end portions 330 and 332 combine to form a fastener
aperture 334 configured to receive the fastener therein. The force
application end portions 330 and 332 each include opposing
compressive members 336 for compressing the fastener about the
suture.
[0110] Referring to FIG. 27 and 29, medical device 320 includes
collett closer 340. The collett closer 340 is positioned on the
outer tube 260 proximal to the force application end portions 330
and 332 of the first and second collett arms 324 and 326. The
collett closer 340 includes slotted sections 342 configured for
receiving end portions of the fastener therein. As the outer tube
260 is moved from the first tube position P1 to the second tube
position P2, the collett closer is moved over the force application
end portions 330 and 332. Similar to collett closer 268, the
collett closer 340 includes inner tapered surfaces 280 (See FIG.
22), such that the inner tapered surfaces 280 apply compressive
forces to the force application end portions 330 and 332 as the
collett closer 340 is moved over the force application end portions
330 and 332, closing the gap 328 there between.
[0111] Referring to FIGS. 30 and 31, in a method of use suture 360
is inserted through the bone 362 and fracture 364, where the suture
360 is threaded through a fastener 366 on a first side (fracture
side) of the bone 362. The suture 360 is reinserted through the
fracture 364 and bone 362, such that first and second ends 368 and
370 of the suture 360 extend from the bone 362. The first and
second ends of the suture 368 and 370 are threaded through a
fastener 372, where the first end of the suture 368 is threaded
through a first aperture 374 in the fastener 372 and the second end
of the suture 370 is threaded through a second aperture 376 in the
fastener 372.
[0112] Referring also to FIG. 26, the ends of the suture 368 and
370 are inserted through the medical device 320 along the central
longitudinal axis A, through the collett 322, collett holder 208,
and the cable tensioner 216, positioning the fastener 372 in the
fastener aperture 334 and extending the ends of the suture 368 and
370 through the cable aperture 224. To tension the suture 360, the
cable tension lever 230 is actuated from the first lever position
L1 to the second lever position L2, sliding the cable tensioner 216
along the collett holder 208 from the first tensioner position T1,
into the handle portion 202 against the tension bias member 238, to
the second tensioner position T2. The suture ends 368 and 370 are
positioned through the radial groove 226 and wrapped about the
circumferential groove 228 on the end portion 222 of the cable
tensioner 216, securing the suture 360 to the cable tensioner 216.
The cable tension lever 230 is released, such that tension bias
member 238 biases the cable tensioner 216 from the second tensioner
position T2 towards the first tensioner position T1. The movement
of the cable tensioner 216 towards the first tensioner position T1
applies tension to the suture 360, compressing the fastener 372
against the bone 362. The applied tension can be selected by
actuating the cable tension lever 230 to the desired tension
marking 240.
[0113] The trigger 264 is actuation from the first trigger position
TR1 to the second trigger position TR2. The actuation of the
trigger 264 slides the outer tube 260 along the collett holder 208
from the first tube position P1 to the second tube position P2,
moving collett closer 340 about the force application end portions
330 and 332 of the first and second collett arms 324 and 326. The
inner tapered surfaces 280 of the collett closer 340 apply
compressive forces to the first and second force application end
portions 330 and 332, compressing compressive members 336 of the
first and second force application end portions 330 and 332 into
the first and second fastener apertures 374 and 376. The
compressive forces crimp the first and second fastener apertures
374 and 376 about the suture ends 368 and 370, securing the
fastener 372 to the suture ends 368 and 370.
[0114] Simultaneously, the actuation of the trigger 264 results in
the top portion 290 of the trigger 264 engaging the cut off cam
ring 288, sliding the cut off cam ring 288 and cut off cam 284
along the collett holder 208. The second end portion 200 of the cut
off cam 283 engages the angular surface 298 of the cutting head
294, forcing the cutting edge 296 into the suture ends 268 and 270,
cutting the suture ends 368 and 370.
[0115] Referring to FIG. 32, similar to FIGS. 18 and 20, a collett
400 is affixed to a second end portion 244 of the collett holder
208, opposite the cable tensioner 216. The collett 400 defines a
collett passage longitudinally aligned with the longitudinal
passage of the collett holder 208 along the central longitudinal
axis A. An end portion of the collett 400 is bisected, forming
first and second collett arms 402 and 404. A gap portion 406 is
provided between the first and second collett arms 402 and 404.
Each of the first and second collett arms 402 and 404 includes
force application end portions 408 and 410. The force application
end portions 408 and 410 combine to form a bushing aperture 412
configured to received the bushing therein 414. The collett 400 is
made of a semi-rigid material, such that the first and second
collett arms 402 and 404 can be moved from an open to a closed
position, closing the gap 406 between the force application end
portions 408 and 410.
[0116] Referring also to FIG. 33, in a method of use, suture 416 is
inserted through the bone 418 and fracture 420, where the suture
416 is threaded through a fastener 422 on a first side (fracture
side) of the bone 424. The suture 416 is reinserted through the
fracture 420 and bone 418, such that first and second ends 426 and
428 of the suture 416 extend from the bone 418. The first and
second ends of the suture 426 and 428 are threaded through a
fastener 414, where the first and second ends 426 and 428 of the
suture 416 is threaded through an aperture 430 in the fastener
414.
[0117] Referring also to FIGS. 26 and 29, the ends of the suture
426 and 428 are inserted through the medical device 320 along the
central longitudinal axis A, through the collett 400, collett
holder 208, and the cable tensioner 216, positioning the fastener
414 in the fastener aperture 412 and extending the ends of the
suture 426 and 428 through the cable aperture 224. To tension the
suture 416, the cable tension lever 230 is actuated from the first
lever position L1 to the second lever position L2, sliding the
cable tensioner 216 along the collett holder 208 from the first
tensioner position T1, into the handle portion 202 against the
tension bias member 238, to the second tensioner position T2. The
suture ends 426 and 428 are positioned through the radial groove
226 and wrapped about the circumferential groove 228 on the end
portion 222 of the cable tensioner 216, securing the suture 360 to
the cable tensioner 216. The cable tension lever 230 is released,
such that tension bias member 238 biases the cable tensioner 216
from the second tensioner position T2 towards the first tensioner
position T1. The movement of the cable tensioner 216 towards the
first tensioner position T1 applies tension to the suture 416,
compressing the fastener 414 against the bone 418. The applied
tension can be selected by actuating the cable tension lever 230 to
the desired tension marking 240.
[0118] The trigger 264 is actuated from the first trigger position
TR1 to the second trigger position TR2. The actuation of the
trigger 264 slides the outer tube 260 along the collett holder 208
from the first tube position P1 to the second tube position P2,
moving collett closer 340 about the force application end portions
408 and 410 of the first and second collett arms 402 and 404. The
inner tapered surfaces 280 of the collett closer 340 apply
compressive forces to the first and second force application end
portions 408 and 410. The compressive forces crimp the aperture 430
about the suture ends 426 and 428, securing the fastener 414 to the
suture ends 426 and 428.
[0119] Referring to FIG. 36, a medical device 500 is provided for
securing the bushing to the cable. The medical device 500 includes
a handle portion 502 having a tensioning mechanism 504, tensioning
the cable and applying a force to the bushing, and a crimping
mechanism 506 for securing the bushing to the cable.
[0120] Referring also to FIGS. 37 and 38, the tensioning mechanism
504 includes a collett holder 508 defining a longitudinal passage
along a central longitudinal axis A. The collett holder 508 is
affixedly positioned through a top portion 510 of the handle
portion 502. A cable tensioner 512 is slidably positioned on a
first end 514 of the collett holder 508. The cable tensioner 512
defines a cable passage longitudinally aligned with the
longitudinal passage of the collett holder 508. An end portion 516
of the cable tensioner 512 includes a cable aperture for threading
the cable there through. A radial groove and circumferential groove
518 are provided on the end portion 516 of the cable tensioner 512,
such that the cable can be wrapped about the circumferential groove
518 of the cable tensioner 512, thereby preventing relative
movement between the cable and the cable tensioner 512.
[0121] In an exemplary embodiment, the cable tensioner 512 can
include a retention bushing 520 and a tension insert 522. The
tension insert 522 defines a cable passage longitudinally aligned
with the longitudinal passage of the cable tensioner 512. The
retention bushing 520 is positioned about a portion of the tension
insert 522, where an end portion 524 is threaded into the end
portion 516 of the cable tensioner 512. An opposite end portion 526
of the tension insert 522 includes a cable aperture 528 for
threading the cable there through. A radial groove 530 is provided
on the end portion 526 of the cable tensioner 512 and the retention
bushing 520 and the tension insert 522 combine to form a
circumferential groove 532, such that the cable can be wrapped
about the circumferential groove 532, thereby preventing relative
movement between the cable and the cable tensioner 512.
[0122] A cable tension lever 534 is pivotally connected to the
cable tensioner 512 with a lever pin 536. The cable tension lever
534 is adjustably positioned on the handle portion 502 with body
pins 538, wherein a body pin 538 is mirrorly positioned on opposite
sides of the handle portion 502. The body pins 538 are engaged in
the cable tension lever 536 arcuate lever slots 540, such that
cable tension lever 534 and cable tensioner 512 are movably
connected to the handle portion 502.
[0123] In use, as the cable tension lever 534 is pivoted about the
cable tensioner 512 from a first lever position L1 to a second
lever position L2, the body pins 538 traverse the arcuate lever
slots 540, resulting in a translation of the cable tensioner 512
along the first end 514 of the collett holder 508 from a first
tensioner position T1 to a second tensioner position T2. A tension
bias member 542 is interposed between the cable tensioner 512 and
the handle portion 502, biasing the cable tensioner 512 into the
first tensioner position T1.
[0124] Referring to FIGS. 37 and 39, a collett 544 is affixed to a
second end portion 546 of the collett holder 508, opposite the
cable tensioner 512. The collett 544 defines a collett passage
longitudinally aligned with the longitudinal passage of the collett
holder 508 along the central longitudinal axis A. An end portion of
the collett 544 is bisected, forming first and second collett arms
548 and 550. A gap portion 552 is provided between the first and
second collett arms 548 and 550. Each of the first and second
collett arms 548 and 550 includes force application end portions
554 and 556. The force application end portions 554 and 556 combine
to form a bushing aperture 558 configured to received the bushing
therein. The collett 544 is made of a semi-rigid material, such
that the first and second collett arms 548 and 550 can be moved
from an open to a closed position, closing the gap 552 between the
force application end portions 554 and 556.
[0125] In use, the tensioning mechanism 504 is used to tension the
cable. The cable can include single or multiple filaments. The
cable is inserted through the medical device 500 along the central
longitudinal axis A, through the collett 544, collett holder 508,
and the cable tensioner 512, positioning the bushing in the bushing
aperture 558 and extending the cable through the cable aperture
530. To tension the cable, the cable tension lever 354 is actuated
from the first lever position L1 to the second lever position L2,
sliding the cable tensioner 512 along the collett holder 508 from
the first tensioner position T1, into the handle portion 502
against the tension bias member 542, to the second tensioner
position T2. The cable is positioned through the radial groove 528
and wrapped about the circumferential groove 532 on the between the
retention bushing 520 and the tension insert 522, securing the
cable to the cable tensioner 512. The cable tension lever 534 is
released, such that tension bias member 542 biases the cable
tensioner 512 from the second tensioner position T2 towards the
first tensioner position T1. The movement of the cable tensioner
512 towards the first tensioner position T1 applies a tension to
the cable, forcing the bushing into the second fastener. The
applied tension can be selected by actuating the cable tension
lever 534 to the desired tension.
[0126] Referring to FIGS. 36 and 40, the crimping mechanism 506
includes an outer tube 560 slidingly positioned over the collett
holder 508. The outer tube 560 includes a first end 562 operably
connected to a trigger 564 and a second end 566 connected to a
collett closer 568. The trigger 264 is pivotally mounted in the
handle portion 502, such that the trigger 564 can be actuated from
a first trigger position TR1 to a second trigger position TR2. A
locking mechanism 570 prevents the trigger 564 from being actuated.
The locking mechanism 570 is disengaged by rotating it away from
the handle, where the locking mechanism is secured to the trigger
with the locking pawl 572. (See also FIG. 37).
[0127] The operable connection between the first end of the outer
tube 562 and the trigger 564 includes an outer tube ferrule 574
slidably positioned about the collett holder 408 and affixed to the
first end of the outer tube 562. A tube bias member 576 is
interposed between the handle portion 502 and the outer tube
ferrule 574, such that the tube bias member 576 biases the outer
tube ferrule 574 and the outer tube 560 into a first tube position
P1. A tube washer 578 can be provided between the tube ferrule 574
and the bias member 576.
[0128] An actuation of the trigger 564 from a first trigger
position TR1 to a second trigger position TR2 translates the outer
tube ferrule 574 along the collett holder 208 from the first tube
position P1 to a second tube position P2. In the second tube
position P2 a tube pawl 580 engages the outer tube ferrule 574,
hold the outer tube ferrule in the second tub position P2.
[0129] Referring to FIGS. 36 and 42, the collett closer 568 is
positioned on the outer tube 560 proximal to the force application
end portions 554 and 556 of the first and second collett arms 548
and 550. As the outer tube 560 is moved from the first tube
position P1 to the second tube position P2, the collett closer 568
is moved over the force application end portions 554 and 556. The
collett closer 568 includes inner tapered surfaces 582, such that
the inner tapered surfaces 580 apply compressive forces to the
force application end portions 554 and 556 as the collett closer
568 is moved over the force application end portions 554 and 556,
closing the gap 552 there between.
[0130] In use, the trigger 564 is actuated from the first trigger
position TR1 to the second trigger position TR2. The actuation of
the trigger 564 slides the outer tube 560 along the collett holder
508 from the first tube position P1 to the second tube position P2,
moving collett closer 568 about the force application end portions
554 and 556 of the first and second collett arms 548 and 550. The
inner tapered surfaces 580 of the collett closer 568 apply
compressive forces to the first and second force application end
portions 554 and 556, closing the gap 552 there between.
[0131] Referring to FIGS. 41-43, the crimping mechanism 506 can
further include a cutting mechanism. The cutting mechanism includes
a pair of cut off cams 582 and 584 positioned in the collett gap
552. A pair of wedges 586 and 588 are slidingly positioned along
and on opposite sides of the collett 550 and the collett holder
508. Each of the wedges 586 and 588 include tapered ends 590 and
592 positioned proximal to the cut off arms, such that when the
wedges are moved from a first wedge position W1 to a second wedge
position W2, the tapered ends 590 and 592 compress the cut off cams
582 and 584 together, cutting the cable.
[0132] The handle 502 further includes a wedge pusher 594 slidingly
positioned about the collett holder 508, adjacent to second ends
594 and 596 of wedges 586 and 588. The wedge pusher 594 is slidable
from a first position to a second position, such that the wedges
586 and 588 are moved from the first wedge position W1 to the
second wedge position W2. A rocker 596 is pivotally connected to
the handle 502, such that an actuation of the rocker 596 from a
first rocker position R1 to a second rocker position R2, slides the
wedge pusher 594 from the first position to the second position,
moving wedges 586 and 588 from the first wedge position W1 to the
second wedge position W2
[0133] Referring to FIGS. 41 and 44, the locking mechanism 570
includes a rocker kicker 598 pivotally affixed therein. The rocker
kicker 598 is biasedly connected to the locking mechanism 570,
being held in a closed position by a pin 600. When the trigger 564
is actuated from the first trigger position TR1 to the second
trigger position TR2, the release 602 engages the pin 600,
releasing the rocker kicker 590.
[0134] The trigger 564 is released, allowing the trigger 564 to
move from the second trigger position TR2 to the first trigger
position TR1. To actuate the cutting mechanism, the trigger is
again moved from the first trigger position TR1 to the second
trigger position TR2, such that the rocker kicker 598 engages the
rocker 596, pivoting the rocker 596 from the first rocker position
R1 to the second rocker position. The rocker 596 slides the wedge
pusher 594 from the first position to the second position, moving
wedges 586 and 588 from the first wedge position W1 to the second
wedge position W2, such that, the tapered ends 590 and 592 compress
the cut off cams 582 and 584 together, cutting the cable. The
trigger 564 can then be released, releasing the crimped
fastener.
[0135] It is also contemplated that the system and medical device
of the present invention may be disposable or may be sterilized
after use and reused.
[0136] The methods and devices of the present invention may be used
in conjunction with any surgical procedure of the body. The repair,
reconstruction, augmentation, and securing of tissue or an implant
may be performed in connection with surgery of a joint, bone,
muscle, ligament, tendon, cartilage, capsule, organ, skin, nerve,
vessel, or other body part. For example, tissue may be repaired,
reconstructed, augmented, and secured following intervertebral disc
surgery, knee surgery, hip surgery, organ transplant surgery,
bariatric surgery, spinal surgery, anterior cruciate ligament (ACL)
surgery, tendon-ligament surgery, rotator cuff surgery, capsule
repair surgery, fractured bone surgery, pelvic fracture surgery,
avulsion fragment surgery, hernia repair surgery, and surgery of an
intrasubstance ligament tear, annulus fibrosis, fascia lata, flexor
tendons, etc. In one particular application, an anastomosis is
performed over a balloon and the methods and devices of the present
invention are used to repair the vessel.
[0137] Also, tissue may be repaired after an implant has been
inserted within the body. Such implant insertion procedures
include, but are not limited to, partial or total knee replacement
surgery, hip replacement surgery, bone fixation surgery, etc. The
implant may be an organ, partial organ grafts, tissue graft
material (autogenic, allogenic, xenogenic, or synthetic), collagen,
a malleable implant like a sponge, mesh, bag/sac/pouch, collagen,
or gelatin, or a rigid implant made of metal, polymer, composite,
or ceramic. Other implants include biodegradable plates, porcine or
bovine patches, metallic fasteners, compliant bearings for one or
more compartments of the knee, nucleus pulposus prosthetic, stent,
tissue graft, tissue scaffold, biodegradable collagen scaffold, and
polymeric or other biocompatible scaffold. The scaffold may include
fetal cells, stem cells, embryonal cells, enzymes, and
proteins.
[0138] The present invention further provides flexible and rigid
fixation of tissue. Both rigid and flexible fixation of tissue
and/or an implant provides compression to enhance the healing
process of the tissue. A fractured bone, for example, requires the
bone to be realigned and rigidly stabilized over a period time for
proper healing. Also, bones may be flexibly secured to provide
flexible stabilization between two or more bones. Soft tissue, like
muscles, ligaments, tendons, skin, etc., may be flexibly or rigidly
fastened for proper healing. Flexible fixation and compression of
tissue may function as a temporary strut to allow motion as the
tissue heals. Furthermore, joints which include hard and soft
tissue may require both rigid and flexible fixation to enhance
healing and stabilize the range of motion of the joint. Flexible
fixation and compression of tissue near a joint may provide motion
in one or more desired planes. The fasteners described herein and
incorporated by reference provide for both rigid and flexible
fixation.
[0139] It is contemplated that the devices and methods of the
present invention be applied using minimally invasive incisions and
techniques to preserve muscles, tendons, ligaments, bones, nerves,
and blood vessels. A small incision(s) may be made adjacent the
damaged tissue area to be repaired, and a tube, delivery catheter,
sheath, cannula, or expandable cannula may be used to perform the
methods of the present invention. U.S. Pat. No. 5,320,611 entitled,
Expandable Cannula Having Longitudinal Wire and Method of Use,
discloses cannulas for surgical and medical use expandable along
their entire lengths. The cannulas are inserted through tissue when
in an unexpanded condition and with a small diameter. The cannulas
are then expanded radially outwardly to give a full-size instrument
passage. Expansion of the cannulas occurs against the viscoelastic
resistance of the surrounding tissue. The expandable cannulas do
not require a full depth incision, or at most require only a
needle-size entrance opening.
[0140] Also, U.S. Pat. Nos. 5,674,240; 5,961,499; and 6,338,730
disclose cannulas for surgical and medical use expandable along
their entire lengths. The cannula has a pointed end portion and
includes wires having cores which are enclosed by jackets. The
jackets are integrally formed as one piece with a sheath of the
cannula. The cannula may be expanded by inserting members or by
fluid pressure. The cannula is advantageously utilized to expand a
vessel, such as a blood vessel. An expandable chamber may be
provided at the distal end of the cannula. The above mentioned
patents are hereby incorporated by reference.
[0141] In addition to using a cannula with the methods of the
present invention, an introducer may be utilized to position
fasteners at a specific location within the body. U.S. Pat. No.
5,948,002 entitled Apparatus and Method for Use in Positioning a
Suture Anchor, discloses devices for controlling the placement
depth of a fastener. Also, U.S. patent application Ser. No.
10/102,413 discloses methods of securing body tissue with a robotic
mechanism. The above-mentioned patent and application are hereby
incorporated by reference. Another introducer or cannula which may
be used with the present invention is the VersaStep.RTM. System by
Tyco.RTM. Healthcare.
[0142] The present invention may also be utilized with minimally
invasive surgery techniques disclosed in U.S. patent application
Ser. No. 10/191,751 and U.S. Pat. Nos. 6,702,821 and 6,770,078.
These patent documents disclose, inter alia, apparatus and methods
for minimally invasive joint replacement. The femoral, tibial,
and/or patellar components of a knee replacement may be fastened or
locked to each other and to adjacent tissue using fasteners
disclosed herein and incorporated by reference. Furthermore, the
methods and devices of the present invention may be utilized for
repairing, reconstructing, augmenting, and securing tissue or
implants during and "on the way out" of a knee replacement
procedure. For example, the anterior cruciate ligament and other
ligaments may be repaired or reconstructed; quadriceps mechanisms
and other muscles may be repaired. The patent documents mentioned
above are hereby incorporated by reference.
[0143] In addition, intramedullary fracture fixation and comminuted
fracture fixation may be achieved with the devices and methods of
the present invention. For example, a plate or rod may be
positioned within or against the fractured bone. A fastener may be
driven through or about the bone and locked onto the plate, rod, or
another fastener.
[0144] It is further contemplated that the present invention may be
used in conjunction with the devices and methods disclosed in U.S.
Pat. No. 5,329,846 entitled, Tissue Press and System, and U.S. Pat.
No. 5,269,785 entitled, Apparatus and Method for Tissue Removal.
For example, an implant secured within the body using the present
invention may include tissue harvested, configured, and implanted
as described in the patents. The above-mentioned patents are hereby
incorporated by reference.
[0145] Furthermore, it is contemplated that the methods of the
present invention may be performed under indirect visualization,
such as endoscopic guidance, computer assisted navigation, magnetic
resonance imaging, CT scan, ultrasound, fluoroscopy, X-ray, or
other suitable visualization technique. The implants, fasteners,
fastener assemblies, and sutures of the present invention may
include a radiopaque material for enhancing indirect visualization.
The use of these visualization means along with minimally invasive
surgery techniques permits physicians to accurately and rapidly
repair, reconstruct, augment, and secure tissue or an implant
within the body. U.S. Pat. Nos. 5,329,924; 5,349,956; and 5,542,423
disclose apparatus and methods for use in medical imaging. Also,
the present invention may be performed using robotics, such as
haptic arms or similar apparatus. The above-mentioned patents are
hereby incorporated by reference.
[0146] All references cited herein are expressly incorporated by
reference in their entirety.
[0147] It will be appreciated by persons skilled in the art that
the present invention is not limited to what has been particularly
shown and described herein above. In addition, unless mention was
made above to the contrary, it should be noted that all of the
accompanying drawings are not to scale. A variety of modifications
and variations are possible in light of the above teachings without
departing from the scope and spirit of the invention. Therefore, it
will be understood that the appended claims are intended to cover
all such modifications and embodiments which come within the spirit
and scope of the present invention.
* * * * *